NCT00558701

Brief Summary

This single-center, prospective, randomized, and controlled study evaluated the efficacy of silver-coated dressing with active microcurrent in comparison to silver-coated dressing with sham microcurrent on wound-closure time for autogenous skin donor sites.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 13, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 15, 2007

Completed
16 days until next milestone

Study Start

First participant enrolled

December 1, 2007

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
2.7 years until next milestone

Results Posted

Study results publicly available

June 6, 2016

Completed
Last Updated

June 6, 2016

Status Verified

August 1, 2015

Enrollment Period

5.8 years

First QC Date

November 13, 2007

Results QC Date

August 21, 2015

Last Update Submit

April 26, 2016

Conditions

Burns

Keywords

burnsdonor sitehealingmicrocurrent

Outcome Measures

Primary Outcomes (1)

  • Time to Wound Healing

    Time to 90% confluent reepitheliazation of donor site, as indicator of wound healing

    20 days

Study Arms (2)

Microcurrent Stimulator + Silverlon

ACTIVE COMPARATOR

Patients receiving active electrical stimulation (15-50 microamps) during treatment of skin donor sites with Silverlon wound contact dressing. Intervention is active electrical stimulation via microcurrent stimulator.

Device: Microcurrent stimulatorDevice: Silverlon Wound Contact Dressing

Silverlon alone

SHAM COMPARATOR

Patients receiving treatment of skin donor sites with Silverlon wound contact dressing alone (i.e., without active electrical stimulation)

Device: Silverlon Wound Contact Dressing

Interventions

Microcurrent stimulatorDEVICE

Microcurrent stimulation from 15-50 microamps

Microcurrent Stimulator + Silverlon
Silverlon Wound Contact DressingDEVICE

Silver coated nylon dressing FDA approved for use on donor sites in burn patients

Microcurrent Stimulator + SilverlonSilverlon alone

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • between 18-65 years of age
  • burn less than 30% total body surface area
  • burns not involving donor site area
  • you need skin grafting to cover burns
  • agree not to use other electronic devices that generate current during your study participation
  • agree to come back for follow up visits at least every other day after discharge from hospital until donor site is healed

You may not qualify if:

  • you have an illness that may affect how your wound heals such as diabetes, blood clotting disorder, cirrhosis, liver failure, peripheral vascular disease
  • you are taking medications that could affect how your wound heals such as steroids, Plavix, Coumadin
  • you have an infection of the skin or your bloodstream
  • you are pregnant or nursing
  • you are sensitive or allergic to silver or nylon
  • your burn wounds are more than 30% of your total body surface area
  • your site was previously harvested for grafting
  • you have an implantable pacemaker device

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

USAISR

Fort Sam Houston, Texas, 78234, United States

Location

Related Publications (2)

  • Kauvar DS, Cancio LC, Wolf SE, Wade CE, Holcomb JB. Comparison of combat and non-combat burns from ongoing U.S. military operations. J Surg Res. 2006 May 15;132(2):195-200. doi: 10.1016/j.jss.2006.02.043. Epub 2006 Mar 31.

    PMID: 16580688BACKGROUND

  • Malin EW, Galin CM, Lairet KF, Huzar TF, Williams JF, Renz EM, Wolf SE, Cancio LC. Silver-coated nylon dressing plus active DC microcurrent for healing of autogenous skin donor sites. Ann Plast Surg. 2013 Nov;71(5):481-4. doi: 10.1097/SAP.0b013e31829d2311.

    PMID: 23903090DERIVED

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Results Point of Contact

Title
Leopoldo C. Cancio, COL, MC
Organization
USAISR
leopoldo.c.cancio.mil@mail.mil
210-916-3301

Study Officials

  • Leopoldo C Cancio, MD

    United States Army Institute of Surgical Research

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 13, 2007

First Posted

November 15, 2007

Study Start

December 1, 2007

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

June 6, 2016

Results First Posted

June 6, 2016

Record last verified: 2015-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)